Nifedipine

Product NDC: 68084-598
11-digit product format: 680840598
Labeler code: 68084
Product ID: 68084-598_35460830-1534-dc42-e063-6394a90a1e57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA077127
Marketing category: ANDA
Marketing start: 2013-09-09
Substance: NIFEDIPINE
Active strength: 60 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077127-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21
A077127-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21
A077127-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077127-001	AB2
A077127-002	AB2
A077127-003	AB2

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077127-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077127-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077127-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077127-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077127-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077127-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077127-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077127-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077127-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077127-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077127-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077127-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077127-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077127-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077127-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077127-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077127-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077127-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077127-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077127-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077127-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077127-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077127-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077127-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077127-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077127-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077127-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077127-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077127-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077127-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077127-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077127-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077127-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077127-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077127-002	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077127-003	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077127-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077127-002	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077127-003	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077127-001	AB2	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nifedipine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIFEDIPINE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I9ZF7L6G2L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1812011	Internal RxNorm lookup
1812013	Internal RxNorm lookup
1812015	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b11026f8-dea0-49ac-8725-0ef7dc27923f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bbd94e90-e531-9113-45c1-29860f331640	Product name	7	20230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffd	Product name	4	20220126
308fd2ea-d88a-e021-96c1-7c2ab74d6e4b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68084-598-01	Nifedipine	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED, EXTENDED RE	100	10
68084-598-11	Nifedipine	1 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	1	10
68084-598-65	Nifedipine	50 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	50	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-598-01	EA - Each	68084-598	2b24f2ca-c8c0-4ef0-8cc5-95c4db45d0de	1	2012-07-24
68084-598-11	EA - Each	68084-598	e5de5a96-6d6e-45fd-92aa-bb6bc29c2f27	1	2012-07-24
68084-598-65	EA - Each	68084-598	5aeb9f7c-487c-448e-941f-eafb3746d500	1	2023-03-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIFEDIPINE	ACTIVE INGREDIENT	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
NIFEDIPINE	ACTIVE MOIETY	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-598	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	10	Current NDC, Legacy NDC, 3 package rows	20250522_b11026f8-dea0-49ac-8725-0ef7dc27923f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine ER	NIFEDIPINE	AvPAK	d1a78ff2-7672-3e69-00ef-63d203c80484	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	Chartwell RX, LLC	0a8e3090-7733-4914-bacb-01bbdc8deb30	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	86c1bdae-c749-4ec3-90f6-7ebe8e76c461	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	Cardinal Health 107, LLC	593d8ca3-c303-4512-96a6-d4860e02cd83	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	American Health Packaging	b11026f8-dea0-49ac-8725-0ef7dc27923f	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127 ndc (product): 68084-598
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	75003769-7800-4bc7-b709-35b4caec2c2f	2025-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	Lannett Company, Inc.	331db003-cc8e-4509-9415-20e48c5cc5b2	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	A-S Medication Solutions	ec13ec71-626f-4664-b264-f67ba72071ae	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	Proficient Rx LP	4b6418a8-600f-470e-adf1-56207bb25c38	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I9ZF7L6G2L	NIFEDIPINE	21829-25-4	NIFEDIPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1812011	NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet	PSN	b11026f8-dea0-49ac-8725-0ef7dc27923f	10
1812013	NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet	PSN	b11026f8-dea0-49ac-8725-0ef7dc27923f	10
1812015	NIFEdipine 90 MG Osmotic 24HR Extended Release Oral Tablet	PSN	b11026f8-dea0-49ac-8725-0ef7dc27923f	10
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	b11026f8-dea0-49ac-8725-0ef7dc27923f	10
1812013	Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	b11026f8-dea0-49ac-8725-0ef7dc27923f	10
1812015	Osmotic 24 HR nifedipine 90 MG Extended Release Oral Tablet	SCD	b11026f8-dea0-49ac-8725-0ef7dc27923f	10
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	b11026f8-dea0-49ac-8725-0ef7dc27923f	10
1812013	nifedipine 60 MG Osmotic 24 HR Extended Release Oral Tablet	SY	b11026f8-dea0-49ac-8725-0ef7dc27923f	10
1812015	nifedipine 90 MG Osmotic 24 HR Extended Release Oral Tablet	SY	b11026f8-dea0-49ac-8725-0ef7dc27923f	10
1812011	NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet	PSN	593d8ca3-c303-4512-96a6-d4860e02cd83	8
1812013	NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet	PSN	593d8ca3-c303-4512-96a6-d4860e02cd83	8
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	593d8ca3-c303-4512-96a6-d4860e02cd83	8
1812013	Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	593d8ca3-c303-4512-96a6-d4860e02cd83	8
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	593d8ca3-c303-4512-96a6-d4860e02cd83	8
1812013	nifedipine 60 MG Osmotic 24 HR Extended Release Oral Tablet	SY	593d8ca3-c303-4512-96a6-d4860e02cd83	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-598-01	68084059801	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-598-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-598-11)	100 blister pack	2013-09-09	0000-00-00	No	No	Current
68084-598-11	68084059811	1 in 1 BLISTER PACK						Historical
68084-598-65	68084059865	50 BLISTER PACK in 1 CARTON (68084-598-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-598-11)	50 blister pack	2023-02-06		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIFEdipine Extended-release Tablets, USP For Oral Use Rx Only 8259701/1024(F)	Cardinal Health 107, LLC	2025-06-09	HUMAN PRESCRIPTION DRUG LABEL	8
NIFEdipine Extended-release Tablets, USP For Oral Use Rx Only 8259701/1024(F)	American Health Packaging	2025-05-16	HUMAN PRESCRIPTION DRUG LABEL	10